The breaded fish fillets contain wheat flour which is not declared in the ingredients statement on the labels, nor is there a wheat allergen statement present on the labels.

VOLUME OF PRODUCT IN COMMERCE

4,200 jars

DISTRIBUTION

Nationwide

The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Switzerland, FL

RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I

PRODUCT

Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Recall # Z-0296-2012

Units being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.

VOLUME OF PRODUCT IN COMMERCE

127 units

DISTRIBUTION

Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II

PRODUCT

LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00065 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0206-2012;

LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00084 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms. Recall # Z-0207-2012;

ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; there are two models used with either the ACT 1 sensor or the ACT III sensor: a) Model Ozone-HTC b) Model BlackJack2 SGH-i617 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0208-2012

LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.

VOLUME OF PRODUCT IN COMMERCE

562 sensors, 532 phones

DISTRIBUTION

Nationwide

PRODUCT

SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. Recall # Z-0209-2012

CODE

SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.

SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.

VOLUME OF PRODUCT IN COMMERCE

142 units

DISTRIBUTION

Nationwide, PR, and Canada

PRODUCT

SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data. Recall # Z-0277-2012

A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.

VOLUME OF PRODUCT IN COMMERCE

123 units

DISTRIBUTION

Nationwide, DC, PR

PRODUCT

Maquet Servo-i ventilator system Device Part number 64 87 800, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0352-2012;

Maquet Servo-S ventilator system Device Part number 66 40 440, 510 k 041223; Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall #Z-0353-2012;

Maquet PC Board PC1772 Spare Part Device Part number 64 67 620, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0354-2012

Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).

VOLUME OF PRODUCT IN COMMERCE

202 units

DISTRIBUTION

Nationwide

PRODUCT

RayStation Version 2.0.0.15 Consult instruction for use. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Recall # Z-0359-2012

The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.

MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual, the ActiveCare DVT devices must only be used with the MCS AC/DC Adaptor. The ActiveCare DVT device could result in the device overheating and render the device unusable.

The specific lots of Maxcem Elite Refill Kit appear not to be authentic.

VOLUME OF PRODUCT IN COMMERCE

18,855 units

DISTRIBUTION

Nationwide and Internationally

PRODUCT

Dental cement under the brand name a) Cement-It, Part No. N33, N33A; and b) Natural Elegance (private label of Cement-It) Part No. SHN9004110. The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It), are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives. Recall # Z-0454-2012

During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

VOLUME OF PRODUCT IN COMMERCE

48,489 units

DISTRIBUTION

Nationwide and New Zealand

PRODUCT

Portal Vision, R-Arm with 4D Integrated Treatment Console; Model H80, H81. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment. Recall # Z-0516-2012

The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. This could permit the arm to swing freely when the rotating arm locking lever is released. Should this happen during use, injury to the patient and/or user could occur.

AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.

VOLUME OF PRODUCT IN COMMERCE

1124 units

DISTRIBUTION

Nationwide

PRODUCT

Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced. Recall # Z-0592-2012;

IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Recall # Z-0593-2012

The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged and distributed with ICU Medical Orbit subcutaneous infustion sets, Orbit Micro subcutaneous infusion sets, and IV Start kits. This recall involves those products marked as sterile as well as non-sterile.

VOLUME OF PRODUCT IN COMMERCE

957,990 units

DISTRIBUTION

Nationwide and Internationally

PRODUCT

Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0647-2012;

Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 each --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0648-2012

Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.

VOLUME OF PRODUCT IN COMMERCE

296,580 units

DISTRIBUTION

Nationwide

PRODUCT

NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM. Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500. Recall # Z-0737-2012

CareFusion recently discovered that NicVue versions 2.9.2 and 3.0.1 contains a software issue that may affect some workflows. To prevent this possibility, your NicVue version 2.9.2 must be updated to 2.9.3 and 3.0.1 must be updated to NicVue version 3.0.2. Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams. When the exam record is opened in the device application software, the correct patient name associated with that record is displayed at the top of the screen, but it may not be the intended patient's record.

VOLUME OF PRODUCT IN COMMERCE

1676 (614 Nationwide; 1062 Internationally)

DISTRIBUTION

Nationwide and Internationally

PRODUCT

Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101). The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures; Catalog # 900103. Recall # Z-0830-2012

37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0153-2012;

37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0154-2012;

37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0155-2012;

37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0156-2012;

37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0157-2012

The product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.

VOLUME OF PRODUCT IN COMMERCE

41,744 units

DISTRIBUTION

Nationwide and Internationally

PRODUCT

Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures. Catalog number 7501669. Recall # Z-0806-2012

Water may leak from the irrigation tubing used on the Olympus Flushing Pump.

VOLUME OF PRODUCT IN COMMERCE

64,667 packages of 10 irrigation tubes

DISTRIBUTION

Nationwide

PRODUCT

NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx. The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician. Recall # Z-0826-2012

CODE

Lot 1117911, Exp. 2013-09

RECALLING FIRM/MANUFACTURER

Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by telephone on December 13, 2011, and by letter dated December 14, 2011.